Analysis of Surgical and Oncologic Outcomes After Complete Mesocolic Excision or Non-complete Mesocolic Excision for Right-Sided Colon Cancer

November 18, 2024 updated by: In Ja Park, Asan Medical Center

Analysis of Surgical and Oncologic Outcomes After Compete Mesocolic Excision or Non-complete Mesocolic Excision for Right-Sided Colon Cancer

The goal of this observational study is to investigate the efficacy and safety of a modified D3 lymphadenectomy approach compared to Complete Mesocolic Excision (CME) in patients with right-sided colon cancer. The main question it aims to answer is:

Does a modified D3 approach improve disease-free survival (DFS) in patients with Stage I-III right-sided colon cancer who undergo right-sided colectomy, without increasing surgical complications compared to CME?

Patients with right-sided colon cancer, Stage I-III, who undergo either modified D3 lymphadenectomy or CME as part of their standard treatment, will have their DFS, complications, bleeding volume, number of lymph nodes harvested, and stage distribution compared over a follow-up period. This study ultimately aims to determine the optimal surgical approach for maximizing oncologic outcomes in right-sided colon cancer.

Study Overview

Status

Completed

Conditions

Detailed Description

This observational, population-based, cohort study was conducted following the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. Approval was obtained from the institutional review board (IRB) of the primary institution and the ethics committees of each participating institution in the Republic of Korea. Given that the study utilized anonymized data retrospectively, the need for informed consent was waived.

The study aimed to evaluate the efficacy and safety of modified D3 lymphadenectomy compared to Complete Mesocolic Excision (CME) in patients with right-sided colon cancer. Patients with right-sided colon cancer who underwent laparoscopic or robotic right hemicolectomy from 2013 to 2020 were included. Patients were classified into those who received modified D3 lymphadenectomy or CME, and the study assessed disease-free survival (DFS), surgical complications, bleeding volume, lymph node yield, and stage distribution.

Data collection was carried out at multiple tertiary medical centers across the Republic of Korea, ensuring a broad representation of patient demographics and clinical practices. The participating institutions included Asan Medical Center, Korea University Anam Hospital, Severance Hospital, and Kyungpook National University Chilgok Hospital. These centers vary in location and size, enhancing the study's generalizability within the context of right-sided colon cancer management in Korea.

Study Type

Observational

Enrollment (Actual)

3787

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study included patients who underwent laparoscopic or robotic right hemicolectomy from 2013 to 2020 at four institutions: Asan Medical Center, Kyungpook National University Chilgok Hospital, Korea University Anam Hospital, and Yonsei University Severance Hospital.

Description

Inclusion Criteria:

  • Patients who underwent laparoscopic or robotic right hemicolectomy from 2013 to 2020
  • Patients who received curative right hemicolectomy with lymphadenectomy

Exclusion Criteria:

  • Familial adenomatous polyposis (FAP)
  • Hereditary non-polyposis colon cancer (HNPCC)
  • Patients with inflammatory bowel disease
  • Patients with synchronous malignancies in other organs
  • Patients with non-adenocarcinoma histology of colon cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients who underwent laparoscopic or robotic right hemicolectomy with CME from 2013 to 2020
Patients who underwent laparoscopic or robotic right hemicolectomy with Complete mesocolic excision from 2013 to 2020 in 4 centers
Patients who underwent laparoscopic or robotic right hemicolectomy with modifiedD3 from 2013 to 2020
Patients who underwent laparoscopic or robotic right hemicolectomy with modified D3 lymphadenectomy from 2013 to 2020 in 4 centers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence free survival
Time Frame: Outcome measures will be assessed at 5 years post-surgery.
Recurrence-Free Survival (RFS) between patients who underwent modified D3 and CME procedures from 2013 to 2020.
Outcome measures will be assessed at 5 years post-surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of complication rates between modified D3 and complete mesocolic excision
Time Frame: The outcomes will be assessed to determine if any events occurred post-surgery up to October 2024
This study will compare the complication rates between modified D3 (mD3) lymphadenectomy and Complete Mesocolic Excision (CME).
The outcomes will be assessed to determine if any events occurred post-surgery up to October 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Korea University Anam Hospital
Kyungpook National University Chilgok Hospital
Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

November 10, 2024

First Submitted That Met QC Criteria

November 10, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mD3 domestic

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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